Table 2. Studies of the safety and efficacy of propofol administered

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Table 2. Studies of the safety and efficacy of propofol administered for sedation in adults during endoscopic procedures by other than
anesthesia personnel
Researcher(s) (Year),
Design
Sample, Setting, Methods
Results and Conclusions
Country
Cohen et al. (2003),
Prospective descriptive
819 consecutive endoscopic
The dose of propofol was negatively
United States
study
examinations in adults under
correlated with age and ASA class,

Level VI evidence
sedation with propofol (63 + 33.5
positively correlated with patient’s
(Melynk & Fineout-
mg), midazolam (1 + 0.12 mg),
weight and duration of examination. No
Overholt, 2005)
and meperidine (48 + 7.2 mg); 638
supplemental oxygen was given
colonoscopies and 181
routinely. Hypotension (> 20 mmHg
esophagogastroduodenoscopies
decline in either systolic or diastolic
(EGDs).
blood pressure) developed in 27% adults,
and hypoxemia (oxygen saturation <
90%) developed in 9%. All episodes of
hypotension and hypoxemia were
transient, and no patient required
administration of an antagonist or
assisted ventilation. The average time for
recovery after colonoscopy was 25
minutes and after EGD was 28 minutes.
No procedure was terminated because of
inadequate sedation/analgesia. The
researchers concluded that propofol
potentiated by small doses of midazolam
and meperidine can be safely
administered by specially trained
registered nurses and medical assistants
under the supervision of a
gastroenterologist. All
gastroenterologists and registered nurses
were ACLS certified. Typically
procedures were completed with a
gastroenterologist and one endoscopy
assistant.
Heuss et al. (2003),
Prospec-tive descriptive
2,574 adults undergoing 3,475
No major complications occurred
Switzerland
study
endoscopic procedures (upper
because of the use of propofol, but
 Level VI evidence
endoscopy, colonoscopy, ERCP,
overall decreases in the mean values for
(Melynk & Fineout-
and endoscopic ultrasonography).
oxygen saturation (-2%), arterial pressure
Overholt, 2005)
Propofol was administered by
(-18%), and pulse rate (-10%) were
registered nurses under the
observed. Hypoxemia probably induced
supervision of the
by sedation with propofol occurred in
gastroenterologist.
43/2,574 patients (1.7%) of patients). In
Patients undergoing colonoscopy
the other 37 patients, simply arousing the
also received meperidine 12.5-25
patient and providing additional oxygen
mg IV for analgesia prior to
resolved the problem in < 1 minute. In
propofol, resulting in a lower dose
six (0.3%) of these patients, intervention
of propofol being needed.
was required consisting of insertion of a
nasopharyngeal tube or manual mask
ventilation for < 2 minutes. In seven
(0.3%) of these patients with persistent
bradycardia, atropine was administered.
Patients in ASA Classes III and IV had
an increased risk of developing or more
of these minor adverse events. The
researchers concluded that the
administration of propofol by registered
nurses, with careful monitoring under the
supervision of the gastroenterologist, is
safe for conscious sedation during
endoscopic procedures.
Rex, Heuss, Walker, &
Retrospective chart
36,743 adults receiving nurse-
There were no episodes of endotracheal
Rong (2005), United
review
administered propofol sedation at
intubation, death, or neurologic or
States

three centers—two academic
permanent injury. The rate of bag-valve-
Level VI evidence
Sweden
(Melynk & Fineout- hospitals in Indiana, U.S., and
mask ventilation was in the order of
Overholt, 2005)
Sweden and an ambulatory
1/500 to 1/1,000 cases. The authors
surgery center in Oregon, U.S.
concluded that propofol can be given
Patients of ASA > III were
safely by appropriately trained nurses
excluded. Procedures were limited
under the supervision of endoscopists.
to EGD and colonoscopies at the
U.S. centers, and in addition, some
endoscopic ultrasounds and
endoscopic retrograde
cholangiopancreatography (ERCP)
were included at the Swiss center.
Saenz-Lopez et al.
Prospec-tive descriptive
102 consecutive endoscopies (60
There was no statistically significant
(2005), Spain
study
colonoscopies and 42 EGDs) in
difference in mean dose of propofol used
 Level VI evidence
adults. In 27 (26.5%) endoscopies,
for EGDs and that used for
propofol was administered alone,
colonoscopies. The mean dose of
(Melynk & Fineout-
Overholt, 2005)
and in 75 endoscopies (73.5%),
propofol when infused alone was 84.8
propofol was combined with
mg and in combination with
benzodiazepines and/or opiods.
benzodiazepines/opiods was 66.9 mg. In
All patients were given 4 L/minute
colonoscopies, the doses of propofol
of supplemental oxygen by nasal
required were lower when combined with
cannula.
midazolam and/or meperidine and in
patients over 65 years of age (p = 0.006
and p = 0.001, respectively). Eleven mild
to moderate adverse effects were
managed by the endoscopist (two
vasovagal reactions treated with atropine,
a paradoxical reaction to midazolam, and
eight episodes of mild desaturation that
were corrected by an increase in oxygen
flow rate or administration of antidotes.
The adults had no memories of the
procedure and would be willing to
receive the same sedation should the
procedure need to be repeated in the
future. Although all procedures were
completed, tolerance was rated by the
endoscopist as excellent/good (83%), fair
(5%), and bad/very bad (12%) of EGDs
and excellent/good (79%), fair (8%), and
bad/very bad (13%) of colonoscopies.
The researchers concluded that the
administration of propofol by the
endoscopist and assistant nurse is an
effective and safe method of sedation in
adults of both low and high risk as well
as elderly patients. The dose of propofol
required for an adequate sedation was
lower in patients over 65 years and when
the medications were combined. The
administration of sedation by the
endoscopist who performed the
procedure or by one assistant nurse is
safe and effective. There was no
additional person dedicated to monitoring
the patient and administering the
sedation. The endoscopist was ACLS
certified and the nurse was trained in
resuscitation skills.
Sipe et al. (2002),
Blinded RCT
80 ambulatory adults (ASA Class I The mean dose of propofol dose was 218
United States
 Level II evidence
or II) undergoing colonoscopy
+ 94 mg; mean doses of midazolam and
(Melynk & Fineout-
alone were randomized to receive
meperidine were 4.7 + 1.5 mg and 89.7 +
Overholt, 2005)
either propofol or midazolam plus
29.1 mg, respectively. Mean time to
meperidine by a nurse supervised
sedation was faster in the propofol group
by an endoscopist. The only task
(2.1 versus 7.0 min; p < 0.0001) and
of the nurse was to sedate and
depth of sedation was greater (4.7 + 0.6
monitor the patient. All
versus 3.8 + 1.1, p < 0.0001) compared
medications were given by an
to the midazolam + meperidine group.
induction IV bolus and then
Four patients in the midazolam +
supplemental IV boluses were
meperidine group developed minor
titrated to maintain a state of
complications (one hypotension and
minimal to mild pain while
bradycardia, two hypotension alone, and
maintaining adequate cardio-
one tachycardia) and one patient in the
respiratory function. All patients
propofol group had oxygen desaturation
received 4 L/min supplemental
develop during epistaxis. On average, the
oxygen.
patients receiving propofol recovered
faster and were discharged sooner (40.5
versus 71.1 min) (p < 0.0001). Patients
who received propofol expressed greater
overall mean satisfaction on a 10-point
visual analog scale (9.3 versus 8.6, p <
.05). At discharge, the propofol group
had better scores on tests reflective of
learning, memory, working memory
span, and mental speed.
The researchers concluded that for
ambulatory colonoscopy, propofol
administered by specially trained nurses
supervised by endoscopists has several
advantages over midazolam plus
meperidine and deserves additional
investigation.
Tohda et al. (2006),
Retrospective chart
27,500 adults undergoing EGD
6.7 % of patients developed oxygen
Japan
review
and/or colonoscopy with nurse-
desaturation (< 90%), and 6.2% required
 Level VI evidence
adminstered propofol sedation.
supplemental oxygen.
Exclusion criteria included
Only 121/27,500 (0.62%) developed
(Melynk & Fineout-
Overholt, 2005)
patients with apparent difficult
oxygen saturation < 85%, and no patient
airways, medication allergies, or
required bag-valve-mask ventilation or
ASA V status.
endotracheal intubation.
Supplemental oxygen was not
Hypotension (systolic blood pressure <
routinely administered.
90 mmHg) was seen in 3.5% of patients;
this responded to intravenous saline.
Patient satisfaction was high.
The authors concluded that nurseadministered propofol sedation under the
supervision of an endoscopist was safe.
VanNatta & Rex (2006),
RCT
200 adults undergoing
Patients receiving propofol alone
United States

Level II evidence
colonoscopy randomized to 1 of 4
received higher doses of propofol and
(Melynk & Fineout-
treatment arms: propofol alone
had deeper sedation scores compared
Overholt, 2005)
titrated to deep sedation or
with combination therapy (both p <
propofol and fentanyl, propofol
0.001). Patients receiving combination
and midalozolam, or propofol,
regimens were discharged more quickly
midazolam and fentanyl, all three
(median 13.0 and 14.7 versus 18.1
titrated to moderate sedation.
minutes) than those receiving propofol
alone (p < 0.01). There were no
differences in vital signs or oxygen
saturations among the study arms. There
were no significant differences in pain or
satisfaction among the study arms in the
recovery area. At follow-up telephone
calls, patients receiving fentanyl and
propofol remembered more of the
procedure than those in the other study
arms (p < 0.005) and remembered more
pain than those receiving propofol alone
(p < 0.02). The researchers concluded
that combining propofol with midazolam
and/or fentanyl allowed a significant
reduction in propofol use without an
impact on patient satisfaction or postprocedural recovery.
Yusoff et al. (2004),
Prospective descriptive
500 adults ASA Class I-II
There were no major adverse events.
Quebec, Canada
study
undergoing endoscopic ultrasound. Mild hypoxemia (oxygen saturation <

Level VI evidence
Propofol was administered by the
90%) occurred in 1% of patients that
(Melynk & Fineout-
endoscopist performing the
responded to increasing the flow rate of
Overholt, 2005)
procedure as an intravenous bolus
oxygen per nasal cannula to 4 L/minute,
followed by a constant infusion.
jaw lift, or temporary cessation of the
propofol infusion. The desaturations
were caused by upper airway obstruction
as a result of propofol-induced hypotonia
rather than hypoventilation. There were
no episodes of hypotension or
bradycardia. The endoscopist rated 92%
of procedures as “very smooth” or
“smooth” and regarded administration of
propofol as easy. All patients reported
they would prefer the same sedation if
the procedure were repeated. The
endoscopist was ACLS certified and the
nurses were BCLS certified. The authors
concluded that although safe, the use of
propofol was more stressful and labor
intensive for the endoscopist compared
with conventional sedation with
midazolam and meperidine. Constant
attention was required from beginning to
end of the infusion and episodes of
propofol-induced oxygen desaturation,
even when mild, engendered greater
anxiety for the entire endoscopy team.
Because of the absence of a dedicated
person to monitor the patient, relatively
conservative loading and infusion doses
of propofol were used resulting in undersedation with frequent gagging during
intubation and coughing during the
procedure. Also, there were more
procedure interruptions. Therefore, the
researchers concluded given the inherent
peculiarities of propofol-induced
sedation, it may be best to reserve its use
for patients in whom standard sedation is
expected to be inadequate.
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